UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031741 |
|---|---|
| Receipt number | R000036014 |
| Scientific Title | Feasibility study of opioid-induced nausea and vomiting |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2019/08/12 20:56:47 |
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Basic information
Public title
Feasibility study of opioid-induced nausea and vomiting
Acronym
Feasibility study of opioid-induced nausea and vomiting
Scientific Title
Feasibility study of opioid-induced nausea and vomiting
Scientific Title:Acronym
Feasibility study of opioid-induced nausea and vomiting
Region
| Japan |
Condition
Condition
Opioid-induced nausea and vomiting (OINV)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore impacts of dexamethasone for improving general condition of cancer patients on OINV for planning a clinical trial of OINV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate at 72 hour after initiation of opioids
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexamethasone
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or clinically confirmed malignant disease
2) Age >= 20 years
3) Planned regular doses of morphine, oxycodone, hydromorphone, codeine or tramadol >= 15mg/day MEDD
4) No prior opioid use within 21 days
5) No prior systemic steroid >5 mg PSL equivalent within 7 days
6) No nausea or vomiting within 7 days
7) No regular use of antiemetics, peristaltic enhancer or antipsychotics
8) Laboratory tests within 14 days meet criteria
9) Orally ingestible
10) Clear consciousness
11) Ability to fill out patient diary
12) Written informed consent
Key exclusion criteria
1) Brain metastasis with edema or meningeal carcinomatosis
2) Peritoneal dissemination, intestinal obstruction or intestinal stenosis with intestinal dilation
3) Constipation >= Grade 3
4) History of diabetes requiring medication
5) Administration of antineoplastic agents with high or moderate emetic risk within 21 days
6) Administration of antineoplastic agents with low emetic risk within 7 days
7) Abdominal surgery within 21 days
8) Infection requiring systemic treatment
9) Active peptic ulcer
10) History of HBV infection
11) Delirium within 1 year
12) History of steroid psychosis
13) Allergy to dexamethasone
14) Other conditions inappropriate for participating in the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuko Aruga / Nobuhiko Seki |
Organization
Teikyo University School of Medicine
Division name
Dpt. Palliative Medicine / Oncology
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
earuga@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Takagi |
Organization
Teikyo University School of Medicine
Division name
Dpt. Palliative Medicine
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
ytakagi@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
帝京大学病院（東京都）、がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036014
